Frequency of multiple changes to prespecified primary outcomes of clinical trials completed between 2009 and 2017 in German university medical centers: A meta-research study

• Martin Holst ,

  Roles Conceptualization, Data curation, Formal analysis, Investigation, Methodology, Visualization, Writing – original draft

  * E-mail: martin.holst@bih-charite.de

  ¶‡ MH and MH share first authorship on this work. LGH and BGC are joint senior authors on this work.

  Affiliations QUEST Center for Responsible Research, Berlin Institute of Health at Charité–Universitätsmedizin Berlin, Berlin, Germany, Institute for Ethics, History and Philosophy of Medicine, Medizinische Hochschule Hannover, Hannover, Germany

  https://orcid.org/0000-0002-8135-6265

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• Martin Haslberger ,

  Roles Formal analysis, Investigation, Methodology, Visualization, Writing – original draft

  ¶‡ MH and MH share first authorship on this work. LGH and BGC are joint senior authors on this work.

  Affiliation QUEST Center for Responsible Research, Berlin Institute of Health at Charité–Universitätsmedizin Berlin, Berlin, Germany

  https://orcid.org/0000-0002-8067-2856

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• Samruddhi Yerunkar,

  Roles Investigation, Writing – review & editing

  Affiliation QUEST Center for Responsible Research, Berlin Institute of Health at Charité–Universitätsmedizin Berlin, Berlin, Germany

  https://orcid.org/0000-0002-0748-383X

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• Daniel Strech,

  Roles Conceptualization, Funding acquisition, Writing – review & editing

  Affiliation QUEST Center for Responsible Research, Berlin Institute of Health at Charité–Universitätsmedizin Berlin, Berlin, Germany

  https://orcid.org/0000-0002-9153-079X

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• Lars G. Hemkens ,

  Roles Conceptualization, Methodology, Supervision, Writing – review & editing

  ¶‡ MH and MH share first authorship on this work. LGH and BGC are joint senior authors on this work.

  Affiliations Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland, Meta-Research Innovation Center Berlin, QUEST Center for Responsible Research, Berlin Institute of Health at Charité–Universitätsmedizin Berlin, Berlin, Germany, Meta-Research Innovation Center at Stanford, Stanford University, Stanford, California, United States of America, Pragmatic Evidence Lab, Research Center for Clinical Neuroimmunology and Neuroscience (RC2NB), University Hospital Basel and University of Basel, Basel, Switzerland

  https://orcid.org/0000-0002-3444-1432

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• Benjamin G. Carlisle

  Roles Conceptualization, Methodology, Software, Supervision, Validation, Writing – review & editing

  ¶‡ MH and MH share first authorship on this work. LGH and BGC are joint senior authors on this work.

  Affiliation QUEST Center for Responsible Research, Berlin Institute of Health at Charité–Universitätsmedizin Berlin, Berlin, Germany

  https://orcid.org/0000-0001-8975-0649

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